Postanalytic Risk Reduction

in Pathology Results Reporting

Session 281, February 14, 2019

Mahmoud A. Khalifa, MD, PhD,

Professor, University of Minnesota

Mahmoud A. Khalifa, MD, PhD

Has no real or apparent conflicts of interest to report.

Conflict of Interest

• Real-life example of a laboratory error

• The various phases of a laboratory test

• Existing challenges in results reporting

• Proposed strategies for risk reduction with examples of quality

improvement projects

– Discrete date formatting for diagnostic elements

– College of American Pathologists cancer checklists

– Real-time reporting of intraoperative consultation

• Question and answers (discussion)

Agenda

• Identify existing gaps in medical records information systems that

could potentially cause patient harm

• Recognize the human factor role with real-life examples of

laboratory results reporting errors and its mitigation through LIS

innovations

• Compare EHR-integrated and stand alone Laboratory Information

Systems in their abilities to mitigate postanalytic reporting errors

• Define the role of healthcare champions in innovation beyond the

existing systems to develop customized patient safety solutions

• Work with home institutions on the development and adoption of

patient safety initiatives focusing on closing the gaps in laboratory

results reporting

Learning Objectives

• Mrs. O is an 81 year old female with a 3 year past history of breast

cancer. She presented with a one year history of pain in her right

leg and a recent right femur fracture. A biopsy was obtained

during surgical correction of the fracture.

• Pathology diagnosis: Metastatic carcinoma.

• Pathology comment: Malignant cells are strongly positive for

CK7. ER, GCDFP, CK20, TTF1 and CDX2 are negative. These

results are non-specific with markers for breast, lung, colon all

being negative

Mrs. O

• Newly diagnosed metastatic cancer in right femur.

• Cancer cells are ER strongly positive

• It seems like it is a relatively indolent ER-positive metastatic

breast cancer.

• Targeted therapy ± antitumoral therapy for breast cancer is her

first option.

Clinical notes – Assessment and Plan

• Mrs. O is an 81 year old female with a 3 year past history of breast

cancer. She presented with a one year history of pain in her right

leg and a recent right femur fracture. A biopsy was obtained

during surgical correction of the fracture.

• Pathology diagnosis: Metastatic carcinoma.

• Pathology comment: Malignant cells are strongly positive for

CK7. ER, GCDFP, CK20, TTF1 and CDX2 are negative. These

results are non-specific with markers for breast, lung, colon all

being negative

Mrs. O

The clinical care – Pathology circle

Operating Room Histology Lab

Pathologist

Specimen Slide

Healthcare team

Treatment

Start/End

Report

A chain is as strong as

its weakest link

The clinical care – Pathology circle

Operating Room Histology Lab

Pathologist

Specimen Slide

Healthcare team

Treatment

Start/End

Report

Phases of the laboratory test cycle

Pre-

analytic

Analytic

Post-

analytic

The shift with time

Pre-

analytic

Analytic

Post-

analytic

Past Present Future

Patient chart – The 20

century model

Emergence of large healthcare systems

in the 21

century

• Large healthcare systems with multi-billion $$ budgets

dominate the healthcare industry

• Progressive shift to organization-wide Electronic Health

Records (EHR) to serve their multi-site operations

• Pathology informaticians are carved out of the labs and

are embedded in these large systems

• Expectedly, a corporate culture dominated laboratory

informatics

Laboratory Information System (LIS)

• Stand alone

• EHR-based

EHR

LIS

EHR – LIS communication

Test

order

Report

Test

order

• Patient chart

• Authorizing provider

• Procedure (encounter) provider

• Mutidisciplinary providers

• Future/scheduled providers

• Splitting samples

• Referring provider (another

institution)

• Second opinion, external provider

• Patients movement

Addendum

Amendment

Molecular

Send out

Arch Pathol Lab Med 2015;139:319-327

Order-entry and results-reporting

interface in a large tertiary care

system

1. Ambulatory clinic: Authorizing provider

2. Hospitalized patients:

A. Patient still in hospital: Authorizing provider + Current

attending

B. Patient discharged: Authorized provider + Last attending

3. ED: Authorized provider + ED queue

4. Resident clinics: Residents + Attending + Scheduled

encounter provider + Nurse pool

Challenges in large healthcare systems

• Integration of LIS and EHR (stand-alone versus

integrated)

• With IT centralization, labs lose control and influence for

decision making and prioritization

• LIS capital is in competition with other enterprise-wide IT

projects – prioritization is balanced by resources required

for maintenance of older systems

• Effective communication with providers outside the

LIS/EHR

• Efficient and effective reporting – special challenges of

precision medicine

Arch Pathol Lab Med 2015;139:311-318

The long road ahead

• Closing the loop: Importing diagnostic

elements directly into clinical notes and

treatment plans

• Standardized terminology

• How to deal with uncertainty?

Closing the loop

Treatment

plan

Clinical

notes

Pathology

Report

Discrete data formatting of diagnostic

elements

Treatment

plan

Clinical

notes

Pathology

Report

• Storing diagnostic elements as discrete data enable

exporting to other medical records, eliminating the

human factor

• College of American Pathologists (CAP) – Cancer protocols

• Synoptic reporting – Choose from a drop-down menu

• Some customization is allowed (rather limited)

• It is now the standard of practice for CAP accreditation

Use of standardized terminology

Communicating uncertainty

(Heavy reliance on the comment section)

• Reporting immunohistochemistry is the most problematic

• Some providers claimed they ALWAYS read the comment while

others admitted they don’t

• Varying confidence

• Inconsistent use of phrases

Academic Pathology 2016;3:1-7

Intraoperative consultation (IOC) by

pathologists

Preliminary

diagnosis

under 20

minutes

Verbally, by phone

or intercom

Immediate next step

• In most pathology departments IOC is communicated to surgeons

who would later enter their impressions in their operative notes

• In October 2016, our department started a new workflow for real-

time reporting of IOC from our stand alone LIS in the EHR

• Two years later, we assessed the benefits of this strategy

• It is of note that this workflow is built in EHR-integrated systems

• Metrics investigated:

– Utility of this approach to the clinical team

– Its impact on reducing errors

Real-time reporting of intraoperative

consultation (IOC) in EHR

• We extracted data from our stand-alone LIS (2814 consecutive

patient encounters). We joined this list to our EHR database and

extracted corresponding audit regarding review of results in

medical records

• We analyzed the data to determine if IOC results were reviewed

in the medical records during the period of time between the

release of the preliminary IOC result and the final report was filed

in the chart

Is it utilized by clinicians?

• We pulled consecutive cases and compared the IOC diagnosis

with the operative notes

Does it reduce errors?

Number of cases reviewed

Number of

discrepancies

150 before implementation

150 after implementation

– year 1 6

150 after implementation

– year 2 7

TOTAL

• It is built-in for EHR-integrated systems and can be developed in

stand-alone LIS

• Clinicians use it heavily immediately after surgery (communicate

with patient, family, advise other team members of immediate

steps..)

• Clinicians also use it around the time of release of final report to

correlate preliminary versus final results

• It significantly reduces miscommunication between pathologists

and surgeons

• Next step: If stored as a discrete data field, the intraoperative

diagnosis can be exported to the operative note

Real-time reporting of intraoperative

consultation (IOC) in EHR

• The current state of pathology result-reporting in the EHR era is

less than perfect since several communication/documentation

steps are done manually

• Error-reduction strategies are currently implemented to improve

patient safety both in stand alone and EHR-integrated systems

• Healthcare champions will need to continue to work with their

home institutions to develop and adopt patient safety initiative

In closing..

• Please, continue the discussion and I would like to hear

your thoughts and ideas

Mahmoud A. Khalifa, MD, PhD

Director, Anatomic Pathology

Professor, University of Minnesota

mkhalifa@umn.edu

• Please, remember to complete online session evaluation

Questions